It is important to use correct organization and appropriate methods for demonstrating biosimilar comparability to support regulatory filings. Biosimilars go through the same rigorous evaluation of ...

To establish whether clinical-product quality remains constant when making a process change can be a challenging exercise. Limited data availability further complicates the assessment of whether the ...

The success or failure of the development of a biopharmaceutical product is governed by protein stability. Protein stability is considered a critical parameter during manufacturing, production, ...

Forbes contributors publish independent expert analyses and insights. I am the Kester and Brynes Professor at Columbia Business School and a Chazen Senior Scholar at the Jerome A. Chazen Institute for ...

Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of ...

Oxford Review of Education, Vol. 35, No. 2 (April 2009), pp. 205-226 (22 pages) Heated discussions about the comparability of standards between examination subjects have kept Qualification Authorities ...

A statistical procedure based on a quality range is proposed for demonstrating comparability between pre-change and post-change process slopes in an accelerated or stressed stability study. To assess ...

Congress must address how current federal law masks education funding disparities between low- and higher-income students by fixing the so-called comparability loophole. For appendix tables, see the ...

The manufacture of biological products is a complex process that involves continual refinement throughout product development, post-approval and marketing. Reasons to alter the manufacturing process ...

Typical sites for measurement of core temperature include the pulmonary artery and midesophagus, however, these sites are available in a small minority of patients. In lieu of a direct measurement of ...

When Congress passed the No Child Left Behind Act in 2001, it rewrote much of the Elementary and Secondary Education Act, increasing the amount of testing required and demanding that states hold ...

Simply sign up to the Global Economy myFT Digest -- delivered directly to your inbox. Brad Setser is a senior fellow at the Council on Foreign Relations and a former Treasury Department official. Theo ...